NDC 48951-3081 Chelidonium Spongia Special Order

Chelidonium Spongia Special Order

NDC Product Code 48951-3081

NDC Code: 48951-3081

Proprietary Name: Chelidonium Spongia Special Order What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Chelidonium Spongia Special Order What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 48951 - Uriel Pharmacy Inc.
    • 48951-3081 - Chelidonium Spongia Special Order

NDC 48951-3081-5

Package Description: 60 g in 1 TUBE

NDC Product Information

Chelidonium Spongia Special Order with NDC 48951-3081 is a a human over the counter drug product labeled by Uriel Pharmacy Inc.. The generic name of Chelidonium Spongia Special Order is chelidonium spongia special order. The product's dosage form is ointment and is administered via oral form.

Labeler Name: Uriel Pharmacy Inc.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Chelidonium Spongia Special Order Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CHELIDONIUM MAJUS 2 [hp_X]/g
  • COLCHICUM AUTUMNALE WHOLE 2 [hp_X]/g
  • SPONGIA OFFICINALIS WHOLE 2 [hp_X]/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • LANOLIN (UNII: 7EV65EAW6H)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Uriel Pharmacy Inc.
Labeler Code: 48951
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-01-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Chelidonium Spongia Special Order Product Label Images

Chelidonium Spongia Special Order Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Indications & Usage

Directions: FOR TOPICAL USE ONLY.

Dosage & Administration

Apply to skin as needed. Under age 2: Consult a doctor.

Otc - Active Ingredient

Active Ingredients: Chelidonium e flor. 2X, Colchicum e pl. tota 2X, Spongia ex animale 2X

Inactive Ingredient

Inactive Ingredients: Organic olive oil, Lanolin, White petrolatum, Beeswax, Distilled Water

Otc - Purpose

Use: Temporary relief of headache.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Warnings

Warnings: FOR EXTERNAL USE ONLY. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions, if conditions worsen or persist, or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seal is broken or missing.

Otc - Questions

Questions? Call 866.642.2858 Made with care by Uriel, East Troy, WI 53120 www.urielpharmacy.com

* Please review the disclaimer below.

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